Glycopyrrolate
- Product NDC
- 65145-105
- 11-digit product format
- 651450105
- Labeler code
- 65145
- Product ID
- 65145-105_b112c5d5-5992-4b6d-8832-cafe5fdcf87b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glycopyrrolate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Caplin Steriles Limited
- Application
- ANDA211705
- Marketing category
- ANDA
- Marketing start
- 2025-01-25
- Substance
- GLYCOPYRROLATE
- Active strength
- 4 mg/20mL
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Glycopyrrolate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLYCOPYRROLATE | 4 mg/20mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V92SO9WP2I |
| Rxcui | 238212, 1731582, 1731590 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65145-105-01 | Glycopyrrolate | 20 mL in 1 VIAL, MULTI-DOSE | INJECTION | 20 | | 5 |
| 65145-105-10 | Glycopyrrolate | 10 in 1 CARTON | INJECTION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65145-105 | GLYCOPYRROLATE INJECTION [CAPLIN STERILES LIMITED] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250126_765490fa-8378-40c8-9fa7-b0bfa2e1a0a9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65145-105-01 | 65145010501 | 20 mL in 1 VIAL, MULTI-DOSE | 20 ml | | | | | Historical |
| 65145-105-10 | 65145010510 | 10 VIAL, MULTI-DOSE in 1 CARTON (65145-105-10) / 20 mL in 1 VIAL, MULTI-DOSE (65145-105-01) | | 2025-01-25 | 0000-00-00 | No | No | Current |